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January 02, 2008

Zero Tolerance for Risk Means Zero Innovation

Happy New Year to all of our readers.

And, along the lines of "the more things change, the more they stay the same," check out the Wall Street Journal's editorial page today, which inveighs against Congress' (and the media's) zero-tolerance for medical risk.

Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.

The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.

The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.

Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.

Read the whole thing.

Posted by Paul Howard at January 2, 2008 11:17 AM

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